Clinical Trial: Evaluation Of The Efficacy And Safety Of Single Doses Of PF-05089771 In Patients With Primary (Inherited) Erythromelalgia

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double Blind Third Party Open Placebo-Controlled Exploratory Study To Evaluate The Efficacy And Safety Of Single Doses Of PF-05089771 In Patients With Primary (Inherited) Same as current

Current Secondary Outcome:

  • Maximum pain score postdose based on Pain Intensity Numerical Rating Scale scores. [ Time Frame: 0-4 hr postdose ]
  • Duration of time above Pain Intensity Numerical Rating Scale score of 5. [ Time Frame: 0-4hr postdose ]
  • Average pain score post Evoked Pain (EP) timepoint 2 based on Pain Intensity Numerical Rating Scale scores. [ Time Frame: 4-8 hr postdose ]
  • Maximum pain score post Evoked Pain timepoint 2 based on maximum Pain Intensity Numerical Rating Scale scores. [ Time Frame: 4-8h hr postdose ]
  • Duration of time above Pain Intensity Numerical Rating Scale score of 5 in the period post Evoked Pain timepoint 2 [ Time Frame: 4-8 hr postdose ]
  • Average pain score post Evoked Pain timepoint 3 based on Pain Intensity Numerical Rating scale scores [ Time Frame: 8-10 hr postdose ]
  • Maximum pain score post Evoked Pain timepoint 3 based on maximum Pain Intensity Numerical Rating Scale scores [ Time Frame: 8-10 hr postdose ]
  • Duration of time above Pain Intensity Numerical Rating Scale score of 5 post Evoked Pain timepoint 3 [ Time Frame: 8-10 hr postdose ]
  • Average pain score post Evoked Pain timepoint 4 based on Pain Intensity Numerical Rating scale scores [ Time Frame: 24-28 hr postdose ]
  • Maximum pain score post Evoked Pain timepoint 4 based on maximum Pain Intensity Numerical Rating Scale scores [ Time Frame: 24-28 hr postdose ]
  • Duration of time above Pain Intensity Numerical Rating Scale score of 5 post Evoked Pain timepoint 4 [ Time Frame: 24-28 hr postdose ]
  • Patient's global satisfaction with study medication based on categorical rating scale [ Time Frame: 4 hr postdose ]
  • Time to first rescue therapy or medication post dose [ Time Frame: 0-28 hr postdose ]
  • Plasma concentrations of PF-05089771, maximum observed concentration (Cmax), time to maximum concentration (Tmax) [ Time Frame: Day 1 predose, then 0.5hr, 2hr, 4hr, 6hr and 24hr postdose ]
  • Type, incidence and severity of Laboratory test result abnormalities as a measure of safety and toleration [ Time Frame: Day 0, Day 2; 24 hr postdose ]
  • Type, incidence and severity of Adverse Events in study subjects [ Time Frame: up to 28 days post last dose ]
  • Blood pressure changes of clinical significance, as a measure of safety and toleration [ Time Frame: Day -2, Day -1, Predose and 6hr post dose ]
  • Electrocardiogram changes of clinical significance, as a measure of safety and toleration [ Time Frame: Day -2, predose, 6 hr 24 hr post dose ]
  • Pulse rate changes of clinical significance, as a measure of safety and toleration [ Time Frame: Day -2, Day -1, Predose and 6hr post dose ]
  • Reason for first rescue therapy or medication postdose [ Time Frame: 0-28 hr postdose ]


Original Secondary Outcome: Same as current

Information By: Pfizer

Dates:
Date Received: October 18, 2012
Date Started: October 2012
Date Completion:
Last Updated: July 30, 2013
Last Verified: July 2013